Composition and method for reducing blood glucose levels

ABSTRACT

The present invention relates to a composition and method for reducing blood glucose levels in a mammal, such as canines and humans. The composition includes bran, cinnamon, yeast, gelatin, and optionally, wheat germ oil, octacosanol, and/or flavor. The method includes administering the composition to the mammal and, if the composition lacks wheat germ oil, also administering wheat germ oil to the mammal.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/869,396, filed Aug. 26, 2010, which claims benefit of ProvisionalApplication No. 61/275,151, filed Aug. 26, 2009 and ProvisionalApplication No. 61/275,541, filed Aug. 31, 2009, which applications areincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a composition and method for reducingblood glucose levels in a mammal, such as a canine or human. Thecomposition includes bran, cinnamon, yeast, gelatin, and optionally,wheat germ oil, octacosanol, flavor, and/or excipient. The methodincludes administering the composition to the mammal and, if thecomposition lacks wheat germ oil, also administering wheat germ oil tothe mammal.

BACKGROUND OF THE INVENTION

Diabetes is prevalent in humans and other animals, such as companionanimals. It is becoming increasingly prevalent in humans. Control ofblood glucose levels can be achieved by administering insulin or othermedications for type II diabetes. However, insulin or these othermedications may not provide the desired or optimal control of bloodglucose levels or can have significant negative side effects.

Canine diabetes can be a frustrating disease to manage. Insulininjections, dose regulation, dietary and treat restrictions, cataractdevelopment, excess thirst and frequent urination are a few of theissues that cause pet owners to become frustrated and give up treatingtheir canine The owners of a diabetic dog have many demands placed upontheir time and energies and many pets are unnecessarily euthanized. Themany concerns people face are: cost of insulin, time and dedication toadministering the insulin, and the need for adherence to a rigidschedule. In addition, once insulin administration begins, testingbecomes a time consuming process, to regulate the insulin, with frequentvisits to the veterinarian.

There remains a need for compositions that control blood glucose levelsin mammals.

SUMMARY OF THE INVENTION

The present invention relates to a composition and method for reducingblood glucose levels in a mammal, such as a canine or human. Thecomposition includes bran, cinnamon, yeast, gelatin, and optionally,wheat germ oil, octacosanol, flavor, and/or excipient. The methodincludes administering the composition to the mammal and, if thecomposition lacks wheat germ oil, also administering wheat germ oil tothe mammal.

The present composition can include about 10 to about 45 wt-% yeast;about 10 to about 70 wt-% bran; about 2 to about 30 wt-% cinnamon; andabout 5 to about 15 wt-% gelatin. This composition can also includeabout 5 to about 15 wt-% wheat germ oil; about 5 to about 30 wt-%flavoring; about 0.1 to about 2 wt-% octacosanol; about 0.5 to about 3wt-% chromium enhanced yeast; or a plurality thereof.

The present method can include reducing a blood glucose level in asubject in need thereof by administering to the subject a compositioncomprising: about 10 to about 45 wt-% yeast; about 10 to about 70 wt-%bran; about 2 to about 30 wt-% cinnamon; and about 5 to about 15 wt-%gelatin. The composition administered can also include about 5 to about15 wt-% wheat germ oil; about 5 to about 30 wt-% flavoring; about 0.1 toabout 2 wt-% octacosanol; about 0.5 to about 3 wt-% chromium enhancedyeast; or a plurality thereof.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1, 2, 4, 6, 8, 10, 12, and 14-16 are graphs demonstrating thatblood glucose levels in dogs decreased upon introduction of treatmentwith a composition of the present invention.

FIGS. 3, 5, 9, 11, and 13 are graphs that illustrate that blood glucoselevels in dogs increased upon withdrawing a composition of the presentinvention.

FIG. 17 is a graph that illustrates that a human subject'safter-breakfast blood glucose levels decreased upon treatment with acomposition of the present invention (referred to in the Figure asNutralin).

FIG. 18 is a graph that illustrates that a human subject'safter-sugary-breakfast blood glucose levels decreased at a comfortablerate upon treatment with a composition of the present invention(referred to in the Figure as Nutralin).

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a composition and method for reducingblood glucose levels in a mammal, such as a canine or human, in needthereof. The composition includes bran, cinnamon, yeast, gelatin, andoptionally, wheat germ oil, octacosanol, flavor, and/or excipient. In anembodiment, the yeast is or includes brewers yeast. In an embodiment,the bran is or includes wheat bran and oat bran. In an embodiment, theingredients of the composition are natural and non-toxic. Thecomposition can be in edible form, such as a treat or kibble for a dogor a bar, wafer, cracker, or shake for a human.

The present method includes administering the composition to the mammaland, if the composition lacks wheat germ oil, also administering wheatgerm oil to the mammal. The present composition has been proven toreduce blood glucose levels in mammals, such as humans and canines

Embodiments of the composition have also been demonstrated to increaseinsulin sensitivity (e.g., lower the required dose of insulin foreffective glucose control), stabilize blood glucose levels, andameliorate other adverse effects associated with diabetes. In anembodiment, the present composition can reduce the dose of insulin orother medication required for effective control of glucose levels. In anembodiment, the present composition can ameliorate detrimental effectsof diabetes, e.g., type I or type II diabetes. In an embodiment, thepresent composition can ameliorate detrimental effects of insulinresistance.

Embodiments of the Present Composition

In certain embodiments, the present composition can include (Table A):

Ingredient wt-% wt-% wt-% wt-% wt-% wt-% brewer's yeast 10-45 15-4020-35 33 19 22 bran 10-70 20-60 30-50 38 38 44 cinnamon  2-30  5-2510-20 19 10 11 wheat germ oil 0 or 5-15 0 or 6-14 0 or 8-12 10 11gelatin  5-15  6-14  8-12 9 10 11 flavoring 0 or 5-30  0 or 10-25  0 or15-20 11 octacosanol  0 or 0.1-2  0 or 0.2-1.5  0 or 0.3-1 1.6 chromiumenriched yeast  0 or 0.5-3  0 or 0.7-2.5 0 or 1-2  1.6These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table B):

Ingredient wt-% wt-% wt-% wt-% wt-% wt-% brewer's yeast 10-45  15-4020-35 33 19 22 bran, e.g., wheat bran 5-35 10-30 15-25 19 19 22 bran,e.g., oat bran 5-35 10-30 15-25 19 19 22 cinnamon 2-30  5-25 10-20 19 1011 wheat germ oil 0 or 5-15 0 or 6-14 0 or 8-12 10 11 gelatin  5-15 6-14  8-12 9 10 11 flavoring 0 or 5-30  0 or 10-25  0 or 15-20 11octacosanol  0 or 0.1-2  0 or 0.2-1.5  0 or 0.3-1 1.6 chromium enrichedyeast  0 or 0.5-3  0 or 0.7-2.5 0 or 1-2  1.6These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table C):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 18-35  20-25  21-23 22bran 16-60  35-50  42-46 44 cinnamon 8-25 9-20 10-12 11 wheat germ oil8-25 9-20 10-12 11 gelatin 4-17 6-14 10-12 11These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table D):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 18-35  20-25 21-23 22bran, e.g., wheat bran 8-30 20-25 21-23 22 bran, e.g., oat bran 8-3020-25 21-23 22 cinnamon 8-25  9-20 10-12 11 wheat germ oil 8-25  9-2010-12 11 gelatin 4-17  6-14 10-12 11These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table E):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 15-30  15-25  18-20  19bran 10-45  20-40  36-40  38 cinnamon 7-20 8-15 9-11 10 wheat germ oil8-20 8-15 9-11 10 gelatin 3-15 5-12 9-11 10 flavoring or excipient 0 or2-25 0 or 5-20 0 or 10-15 11 octacosanol  0 or 0.2-3  0 or 0.5-2.5 0 or1-2  1.6These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table F):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 15-30 15-25 18-20 19 bran,e.g., wheat bran 10-30 15-25 18-20 19 bran, e.g., oat bran 10-30 15-2518-20 19 cinnamon  7-20  8-15  9-11 10 wheat germ oil  8-20  8-15  9-1110 gelatin  3-15  5-12  9-11 10 flavoring 0 or 2-25 0 or 5-20 0 or 10-1511 octacosanol  0 or 0.2-3  0 or 0.5-2.5 0 or 1-2  1.6These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table G):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 29-50 31-40 32-34 33 bran(e.g., powder) 14-44 30-44 36-40 38 cinnamon 15-40 16-30 18-20 19gelatin  2-15  4-12  8-10 9 chromium enriched yeast 0.8-3   1-2.51.5-1.7 1.6These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table H):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 29-50  31-40 32-34 33bran, e.g., wheat bran powder 7-22 15-22 18-20 19 bran, e.g., oat branpowder 7-22 15-22 18-20 19 cinnamon 15-40  16-30 18-20 19 gelatin 2-15 4-12  8-10 9 chromium enriched yeast 0.8-3    1-2.5 1.5-1.7 1.6These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table I):

Ingredient wt-% wt-% wt-% wt-% wt-% brewer's yeast 2-35 5-25 10-15 12 14bran 5-60 10-40  20-30 24 28 cinnamon 1-20 2-15  5-10 6 7 wheat germ oil1-20 2-15  5-10 6 7 gelatin 1-20 2-15  5-10 6 7 water 20-60  30-45 35-40 38 37 flavoring 0 or 2-30 0 or 5-20 0 or 10-15 7 octacosanol  0 or0.1-2  0 or 0.2-1  0 or 0.3-0.5 1These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table J):

Ingredient wt-% wt-% wt-% wt-% wt-% brewer's yeast 2-35 5-25 10-15 12 14bran, e.g., wheat 2-35 5-25 10-15 12 14 bran bran, e.g., oat bran 2-355-25 10-15 12 14 cinnamon 1-20 2-15  5-10 6 7 wheat germ oil 1-20 2-15 5-10 6 7 gelatin 1-20 2-15  5-10 6 7 water 20-60  30-45  35-40 38 37flavoring 0 or 2-30 0 or 5-20 0 or 10-15 7 octacosanol  0 or 0.1-2  0 or0.2-1  0 or 0.3-0.5 1These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table K):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 10-25 11-20 13-15 14 bran20-50 23-40 26-30 28 cinnamon  4-25  5-15 6-8 7 wheat germ oil  4-25 5-15 6-8 7 gelatin  3-17  5-12 6-8 7 water 20-50 30-45 35-40 37These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table L):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 10-25 11-20 13-15 14 bran,e.g., wheat bran 10-25 11-20 13-15 14 bran, e.g., oat bran 10-25 11-2013-15 14 cinnamon  4-25  5-15 6-8 7 wheat germ oil  4-25  5-15 6-8 7gelatin  3-17  5-12 6-8 7 water 20-50 30-45 35-40 37These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table M):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 9-20 10-15 13-14 12 bran5-35 10-30 22-26 24 cinnamon 4-15  5-10 5-7 6 wheat germ oil 5-15  5-105-7 6 gelatin 3-15  5-10 5-7 6 water 20-50  30-45 35-40 38 flavoring or0 or 3-20 0 or 4-15 0 or 5-10 7 excipient octacosanol  0 or 0.2-2  0 or0.5-1.5  0 or 0.9-1.1 1These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table N):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 9-20 10-15  12-13 12 bran,e.g., wheat bran 2-20 5-15 12-13 12 bran, e.g., oat bran 2-20 5-15 12-1312 cinnamon 4-15 5-10 5-7 6 wheat germ oil 5-15 5-10 5-7 6 gelatin 3-155-10 5-7 6 water 20-50  30-45  35-40 38 flavoring or excipient 0 or 3-200 or 5-15 0 or 10-12 7 octacosanol  0 or 0.1-2  0 or 0.2-1  0 or 0.3-0.51These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table O):

Ingredient wt-% wt-% wt-% wt-% wt-% wt-% brewer's yeast 10-50 15-4520-40 36 21 24 bran 20-70 30-60 40-50 42 42 48 cinnamon  2-30  5-2510-20 21 11 12 wheat germ oil 0 or 5-15 0 or 6-14 0 or 10-13 11 12flavoring 0 or 2-25 0 or 5-20 0 or 10-15 12 octacosanol  0 or 0.2-3  0or 0.5-2.5 0 or 1-2  1.6 chromium enriched yeast  0 or 0.5-3.5  0 or0.7-3  0 or 1.5-2.5 1.8These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table P):

Ingredient wt-% wt-% wt-% wt-% wt-% wt-% brewer's yeast 10-50 15-4520-40 36 21 24 bran, e.g., wheat bran 10-35 15-30 20-25 19 21 22 bran,e.g., oat bran 10-35 15-30 20-25 19 21 22 cinnamon  2-30  5-25 10-20 2111 12 wheat germ oil 0 or 5-15 0 or 6-14 0 or 10-13 11 12 flavoring 0 or2-25 0 or 5-20 0 or 10-15 12 octacosanol  0 or 0.2-3  0 or 0.5-2.5 0 or1-2  1.6 chromium enriched yeast  0 or 0.5-3.5  0 or 0.7-3  0 or 1.5-2.51.8These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table Q):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 18-35 20-30 23-25 24 bran16-60 35-55 46-50 48 cinnamon  8-25  9-20 11-13 12 wheat germ oil  8-25 9-20 11-13 12These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table R):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 18-35  20-30 23-25 24bran, e.g., wheat bran 8-30 20-30 23-25 24 bran, e.g., oat bran 8-3020-30 23-25 24 cinnamon 8-25  9-20 11-13 12 wheat germ oil 8-25  9-2011-13 12These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table S):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 10-30 15-25 20-22 21 bran25-60 35-50 40-44 42 cinnamon  7-20  8-15 10-12 11 wheat germ oil  7-20 8-15 10-12 11 flavoring or excipient 0 or 2-25 0 or 5-20 0 or 10-15 12octacosanol  0 or 0.2-3  0 or 0.5-2.5 0 or 1-2  1.6These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table T):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 10-30 15-25 20-22 21 bran,e.g., wheat bran 10-30 15-25 20-22 21 bran, e.g., oat bran 10-30 15-2520-22 21 cinnamon  7-20  8-15 10-12 11 wheat germ oil  7-20  8-15 10-1211 flavoring or excipient 0 or 2-25 0 or 5-20 0 or 10-15 12 octacosanol 0 or 0.2-3  0 or 0.5-2.5 0 or 1-2  1.6These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table U):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 30-50 31-40 35-37 36 bran(e.g., powder) 20-48 30-46 40-44 42 cinnamon 15-40 16-30 20-22 21chromium enriched yeast 0.8-3   1-2.5 1.5-1.7 1.8These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table V):

Ingredient wt-% wt-% wt-% wt-% brewer's yeast 30-50 31-40 35-37 36 bran,e.g., wheat bran powder 10-24 15-23 20-22 21 bran, e.g., oat bran powder10-24 15-23 20-22 21 cinnamon 15-40 16-30 20-22 21 chromium enrichedyeast 0.8-3   1-2.5 1.5-1.7 1.8These embodiments can include any of the amounts, ranges, or end pointsin the table modified by “about”.

In certain embodiments, the present composition can include (Table W):

Relative Relative Relative Relative Relative Relative Ingredient AmountAmount Amount Amount Amount Amount brewer's yeast 0.7-1.5 0.7-1.50.7-1.5 1 1 1 bran 0.9-1.8 1.5-2.5 1.5-2.5 1.2 2 2 cinnamon 0.4-0.90.3-0.7 0.7-1.5 0.6 0.5 1 wheat germ oil 0.3-0.7 0.7-1.5 0.5 1 gelatin0.2-0.4 0.3-0.7 0.7-1.5 0.3 0.5 1 flavoring 0.7-1.5 1 octacosanol0.03-0.06 0.04 chromium 0.03-0.07 0.05 enriched yeastThe relative amounts are relative only to those in the same column.

The composition can be in any of a variety of forms. A compositionincluding water (e.g., as listed above) can be in the form of a moist,set but not hard, mass. The composition including water can be providedin a packet or other container. The packet can be a unit dose. Thecontainer can include numerous doses of the composition and a scoop orother measuring device to dispense an appropriate single dose. Anappropriate amount of the composition including water can be consumed asa dose by a mammal. An appropriate amount (dose) of the compositionincluding water can be a treat for a dog. An appropriate amount (dose)of the composition including water can be consumed by a human. Anappropriate amount (dose) of the composition including water can bemixed with food or beverage before administering. For example, thecomposition including water can be a component of a bar (e.g., anutritional bar) or a shake (e.g., a nutritional shake). For example,the composition including water can be mixed with a food or beveragebefore consuming the food or beverage.

The composition can be in the form of a powder. For example, acomposition that lacks wheat germ oil and water (e.g., as listed above)can be in the form of a powder. The powder can be in a capsule. Thepowder can be provided in a packet. An appropriate amount of the powdercomposition can be consumed as a dose by a mammal. A packet, for examplecould be a unit dose. A container can include numerous doses of thepowder and a scoop or other measuring device to dispense an appropriatesingle dose. The powder can be mixed with food or beverage beforeadministering. For example, the powder can be a component of a bar(e.g., a nutritional bar) or a shake (e.g., a nutritional shake). Forexample, the powder can be mixed with a food or beverage beforeconsuming the food or beverage. A composition lacking wheat germ oil canbe consumed with a separate dose of wheat germ oil. Or, the wheat germoil can be a component of or mixed into the food or beverage that alsocontains the present composition.

In an embodiment, the present composition includes: about 10 to about 45wt-% yeast; about 10 to about 70 wt-% bran; about 2 to about 30 wt-%cinnamon; and about 5 to about 15 wt-% gelatin. This embodiment of thecomposition can also include: about 5 to about 15 wt-% wheat germ oil;about 5 to about 30 wt-% flavoring; about 0.1 to about 2 wt-%octacosanol; about 0.5 to about 3 wt-% chromium enhanced yeast; or aplurality thereof.

In an embodiment, the bran comprises approximately equal amounts ofwheat bran and oat bran. In an embodiment, the yeast comprises brewersyeast, chromium enhanced yeast, or a mixture thereof; or a pluralitythereof.

In an embodiment, the present composition includes about 22 wt-% brewersyeast; about 44 wt-% bran; about 11 wt-% cinnamon; about 11 wt-%gelatin; and about 11 wt-% wheat germ oil.

In an embodiment, the present composition includes about 17 wt-% brewersyeast; about 34 wt-% bran; about 9 wt-% cinnamon; about 9 wt-% gelatin;about 9 wt-% wheat germ oil; about 17 wt-% flavoring; and about 0.7 wt-%octacosanol.

In an embodiment, the present composition includes about 33 wt-% brewersyeast; about 38 wt-% bran; about 19 wt-% cinnamon; about 9 wt-% gelatin;and about 1.6 wt-% chromium enhanced yeast.

In certain embodiments, the present composition consists essentially ofthe listed ingredients. In certain embodiments, the present compositionconsists of the listed ingredients.

In an embodiment, for making a shake, the present composition includes:about 25 to about 30 (e.g., about 27) wt-% yeast; about 30 to about 35(e.g., about 32) wt-% bran (e.g., bran powder); about 10 to about 20(e.g., about 16) wt-% cinnamon; and about 5 to about 10 (e.g., about 8)wt-% gelatin. This embodiment of the composition can also include: about5 to about 15 (e.g., about 11) wt-% flavoring (e.g., cacao and stevia);about 0.1 to about 2 wt-% octacosanol; about 0.5 to about 1.5 (e.g.,about 1) wt-% chromium enhanced yeast; or a plurality thereof. Thiscomposition can be mixed with a beverage, for example water or milk foradministering. If the composition lacks wheat germ oil, the wheat germoil can be added to the beverage in an appropriate amount or consumedseparately.

In an embodiment, for making a treat, the present composition includes:about 20 to about 30 (e.g., about 25) wt-% yeast; about 45 to about 55(e.g., about 50) wt-% bran (e.g., bran flakes); about 10 to about 15(e.g., about 13) wt-% cinnamon; and about 10 to about 15 (e.g., about13) wt-% gelatin. These dry ingredients can be provided in a container(e.g., a tub or canister) together with a premeasured scoop. Thiscomposition can be mixed with water and wheat germ oil to make a treat.The wheat germ oil can be provided in a second container with thepresent composition.

In an embodiment, the gelatin is optional or the composition lacksgelatin.

Doses of and Methods of Administering the Present Composition

The compositions can be administered to a mammal in an amount effectiveto reduce blood glucose levels, e.g., to acceptable levels. The methodof the present invention can include administering the presentcomposition to a mammal in an amount effective to reduce blood glucoselevels, e.g., to acceptable levels. The method can include administeringa dose, e.g., an effective dose, of the present composition. The methodcan also include administering wheat germ oil, for an embodiment of thepresent composition lacking wheat germ oil. The method can includeadministering one or more unit doses of the present composition. Theunit dose can be, for example, a treat or kibble for a dog or a bar,wafer, cracker, or shake for a human. The dose can be a powder that canbe consumed directly, mixed with food, or mixed with (e.g., suspendedin) a fluid, for example, to make a shake.

In certain embodiments, a dose can be about 5 grams to about 60 grams ofthe present composition, which dose can be administered once, twice, orthree times daily. In certain embodiments, a dose can be about 0.3 gramor 1 gram of the present composition per kilogram of body weight, about0.1 to about 2 g/kg, about 0.2 to about 3 g/kg, or about 0.05 to about 5g/kg. Such a dose can be administered once, twice, or three times daily.In certain embodiments, a dose can be about 5 to about 150 grams of thepresent composition per day, about 20 to about 90 grams per day, orabout 30 to 60 grams per day.

In certain embodiments, for a human, a dose of the present compositioncan be about 5 grams to about 60 grams, about 10 grams to about 50grams, or about 15 to about 30 grams which dose can be administeredonce, twice, or three times daily. In certain embodiments, for a human,a dose can be about 0.3 gram of the present composition per kilogram ofbody weight, about 0.2 to about 1 g/kg, about 0.1 to about 2 g/kg, orabout 0.05 to about 5 g/kg. Such a dose can be administered once, twice,or three times daily. In certain embodiments, for an adult human, a dosecan be about 5 to about 150 grams of the present composition per day,about 10 to about 90 grams per day, or about 20 to 60 grams per day.

In certain embodiments, for a human, a dose of the present compositioncan be about 2 grams to about 20 grams, which dose can be administeredonce, twice, or three times daily. If the embodiment of the presentcomposition lacks wheat germ oil, wheat germ oil can be administeredalso. A suitable dose of wheat germ oil can be about 0.3 to about 3grams (e.g., 1 gram), which can be administered once, twice, or threetimes daily. In certain embodiments, for a human, a dose can be about0.1 gram of the present composition per kilogram of body weight, about0.05 to about 0.2 g/kg, about 0.03 to about 0.3 g/kg, or about 0.01 toabout 1 g/kg, which dose can be administered once, twice, or three timesdaily. If the embodiment of the present composition lacks wheat germoil, wheat germ oil can be administered also. A suitable dose of wheatgerm oil can be about 0.05 to about 2 g/kg, which can be administeredonce, twice, or three times daily. In certain embodiments, for an adulthuman, a dose can be about 5 to about 80 grams of the presentcomposition per day, about 10 to about 40 grams per day, or about 15 to25 grams per day. If the embodiment of the present composition lackswheat germ oil, wheat germ oil can be administered also. A suitable doseof wheat germ oil can be about 1 to about 5 grams per day.

In certain embodiments, for a dog, a dose of the present composition canbe about 5 grams to about 45 grams, which dose can be administered once,twice, or three times daily. In certain embodiments, for a dog, a dosecan be about 1 gram of the present composition per kilogram of bodyweight, about 0.5 to about 2 g/kg, about 0.3 to about 3 g/kg, or about0.2 to about 5 g/kg. Such a dose can be administered once, twice, orthree times daily. In certain embodiments, for a dog, a dose can beabout 10 grams to about 100 grams of the present composition per day,about 5 to about 20 grams per day, about 15 to about 60 grams per day,or about 25 to about 100 grams per day.

For a dog, a dose can be administered in the form of a treat, which canbe about one inch by one inch or one inch in diameter. The compositioncan be supplied as a composition in a container and the dose measuredwith a scoop. The composition can be provided as a powder in a containerwith a premeasured scoop and wheat germ oil can be provided also.

In an embodiment, the present method includes or is a method of reducinga blood glucose level in a subject in need thereof. This method caninclude administering to the subject a composition including: about 10to about 45 wt-% yeast; about 10 to about 70 wt-% bran; about 2 to about30 wt-% cinnamon; and about 5 to about 15 wt-% gelatin.

In an embodiment of the method, the subject also receives, takes, selfadministers, or is administered insulin to control the blood glucoselevel. In an embodiment of the method, the subject also receives insulinto control the blood glucose level. In an embodiment of the method, thesubject also takes insulin to control the blood glucose level. In anembodiment of the method, the subject also self administers insulin tocontrol the blood glucose level. In an embodiment of the method, thesubject also is administered insulin to control the blood glucose level.

In certain embodiments, the present method includes administering thecomposition two hours, one hour, 30 minutes, or 15 minutes before a doseof insulin. In an embodiment, the present method includes administeringthe composition two hours, one hour, 30 minutes, or 15 minutes before ameal.

In an embodiment, the composition administered also includes about 5 toabout 15 wt-% wheat germ oil; about 5 to about 30 wt-% flavoring; about0.1 to about 2 wt-% octacosanol; about 0.5 to about 3 wt-% chromiumenhanced yeast; or a plurality thereof.

In an embodiment, the present method includes administering acomposition in which the bran comprises approximately equal amounts ofwheat bran and oat bran.

In an embodiment, the present method includes administering acomposition in which the yeast comprises brewers yeast, chromiumenhanced yeast, or a plurality thereof.

This method can include administering to the subject a compositionincluding: about 22 wt-% brewers yeast; about 44 wt-% bran; about 11wt-% cinnamon; about 11 wt-% gelatin; and about 11 wt-% wheat germ oil.

This method can include administering to the subject a compositionincluding: about 17 wt-% brewers yeast; about 34 wt-% bran; about 9 wt-%cinnamon; about 9 wt-% gelatin; about 9 wt-% wheat germ oil; about 17wt-% flavoring; and about 0.7 wt-% octacosanol.

This method can include administering to the subject a compositionincluding: about 33 wt-% brewers yeast; about 38 wt-% bran; about 19wt-% cinnamon; about 9 wt-% gelatin; and about 1.6 wt-% chromiumenhanced yeast.

The method can include orally administering the present composition.

The present composition can be in the form of a capsule containing anembodiment of the present composition lacking wheat germ oil and anothercapsule containing wheat germ oil. The present composition can be in theform of a dose of an embodiment of the present composition lacking wheatgerm oil and a dose of wheat germ oil. An embodiment of the presentcomposition lacking wheat germ oil can be provided with instructionsinstructing the subject to take or administer wheat germ oil (e.g., andose or effective dose of wheat germ oil) with the present composition.For example, the present composition can be component of a kit orpackage containing the instructions and an embodiment of the presentcomposition lacking wheat germ oil and.

Mammals that can benefit from the present composition or method includehumans, mammalian companion animals (e.g., pets), and other domesticatedmammals (e.g., livestock). Companion animals that can benefit from thepresent composition or method include dogs, cats, rabbits, and rodents.In an embodiment, the mammal is a human or a dog. In an embodiment, themammal is a cat or a dog. In an embodiment, the mammal is a human. In anembodiment, the mammal is a dog. In an embodiment, the mammal is a cat.

Although not limiting to the present invention, it is believed that, inan embodiment, the present composition and method can contribute tostabilizing blood glucose in a normal range and reduce the degree offluctuations in blood glucose levels. In an embodiment, the presentcomposition and method stabilize blood glucose level.

Ingredients for the Present Composition

The present composition can include yeast (e.g., brewers yeast), bran(e.g., wheat and/or oat bran), cinnamon, gelatin, and optionally, wheatgerm oil, octacosanol, flavor, and/or excipient or filler. Theingredients are commercially available.

Suitable yeast includes brewer's yeast, chromium enhanced yeast,nutritional yeast, or a mixture thereof. An embodiment of brewer's yeastis yeast suitable for fermenting sugars to alcohol in the brewing of,for example, beer, and can be Saccharomyces cerevisiae. In anembodiment, brewers yeast includes, for example, folic acid, aminoacids, biotin, chromium, selenium, manganese, potassium. In anembodiment, brewers yeast includes, for example, all of the essentialamino acids, 14 minerals, and 17 vitamins. In an embodiment, brewersyeast includes, for example, one or more of the B-complex vitaminsthiamin, riboflavin, niacin, B6, pantothenic acid, biotin, folic acid,or a mixture thereof. In an embodiment, brewers yeast includes, forexample, chromium, zinc, iron, phosphorus, magnesium, manganese, andselenium. In an embodiment, brewers yeast includes, for example,contains approximately 16 g of protein per 30 g of powdered yeast. In anembodiment, two tablespoons of brewer's yeast yields about 120micrograms (μg) of chromium, an amount equal to the recommended dailyallowance. The brewer's yeast can be in any of a variety of commerciallyavailable forms (e.g., tablet, flake, or powder) for use in or formaking the present composition.

Chromium enriched yeast is a yeast that has been grown in the presenceof or otherwise supplemented with ionic chromium (e.g., trivalentchromium). In an embodiment, chromium enriched yeast includesinactivated dried whole cell yeast (Saccharomyces cerevisiae) containingelevated levels of chromium. It can be prepared through a yeastfermentation supplemented with low levels of trivalent chromium. Theyeast cream can be pasteurized and then spray dried orroller-dried/grinded. Such chromium enhanced yeast can include 2000-2400μg Chromium per gram of the yeast preparation.

Although not limiting to the present invention, it is believed that acomposition including brewers yeast is more effective at loweringmammalian blood glucose levels than, for example, a compositionincluding as the only yeast bakers yeast.

The present composition includes bran, such as bran of a cereal grain,such as rice, corn (maize), wheat, oats, barley, or millet. In anembodiment, the bran is or includes wheat bran, oat bran or a mixturethereof. Subjects that are intolerant of wheat products can take acomposition including only bran from grains other than wheat, e.g., oatbran. The bran can be in any of a variety of commercially availableforms (e.g., flake or powder) for use in or for making the presentcomposition.

Although not limiting to the present invention, it is believed that onecup of wheat bran contains 99% of the U.S. recommended daily allowance(RDA) of fiber, nine grams of protein, and 34% of the RDA for iron.Wheat bran is also high in protein, magnesium, manganese, niacin,phosphorus, zinc and vitamin B6, and is low in fat, with no cholesterol,and no sugar or sodium. Although not limiting to the present invention,it is believed that a powdered bran is about 25% more concentrated thana corresponding flake form of bran.

Any of a variety of commercially available cinnamon can be employed inthe present composition. Although not limiting to the present invention,in certain embodiments, it is believed that one teaspoon of cinnamoncontains 1 mg of iron, 1 mg of fiber, 28 mg of calcium, vitamin C,manganese, vitamin K, or a mixture thereof. The cinnamon can be in anyof a variety of commercially available forms (e.g., ground or powder)for use in or for making the present composition.

Any of a variety of commercially available wheat germ oil that containssignificant levels of octacosanol can be employed in the presentcomposition. Suitable wheat germ oil is or includes unrefined and/orcold processed wheat germ oil. Suitable wheat germ oil can include over1,000 mcg of octacosanol per tablespoon and can be a good source ofvitamin E. The wheat germ oil can be in any of a variety of commerciallyavailable forms for use in or for making the present composition.

Any of a variety of commercially available gelatin suitable forconsumption by mammals (e.g., humans or canines) can be employed in thepresent composition. The gelatin can be of animal (e.g., porcine)origin. The gelatin can be food-grade and edible. Suitable gelatinincludes lysine, glycine, other amino acids, fatty acids, magnesium,calcium, or a mixture thereof. Although not limiting to the presentinvention, gelatin can be a protein food including 18 amino acids, butnot being a complete source of amino acids. In an embodiment, tryptophanand cysteine are absent, and methionine is present at a relatively lowlevel. Although not limiting to the present invention, gelatin can be agood source of the essential amino acid lysine, which occurs inrelatively low proportions in, for example, cereal products. The gelatincan be in any of a variety of commercially available forms (e.g., powderor the shell of a capsule) for use in or for making the presentcomposition.

Any of a variety of commercially available octacosanol can be employedin the present invention. The octacosanol can contain one or more longchain alcohols, such as triacontanol, tetracosanol, hexacosanol, or amixture thereof. The octacosanol can be in any of a variety ofcommercially available forms (e.g., powder) for use in or for making thepresent composition. Amounts of octacosanol refer to the activeingredient, i.e., the octacosanol itself. In powder form a gram of thepowder can contain, for example, 0.015 grams of octacosanol.

Any of a variety of flavoring, filler, excipient, or combination thereofcan be employed in the present composition. Suitable flavors includestevia, cocoa, or a mixture thereof. Stevia is a sweetener that can beconsumed by diabetics. Stevia may have other beneficial properties aswell. The excipient can be or include a taste masking agent. The presentcomposition can include a preservative, such as an antimicrobial agentand/or antioxidant, in an effective amount for extending the storagelife of the composition.

For making a treat, a bar, or a wafer, the ingredients can be mixed withwater and allowed to set to form a workable solid. Storage of thecomposition can be done at refrigerator temperatures, e.g., about 4° C.After the composition has set, it can be frozen.

As used herein, the phrase “consisting essentially of” refers to acomposition including the listed ingredients and lacking any additionalingredients that would affect blood glucose levels. For example acomposition consisting essentially of listed ingredients does notinclude sugar (e.g., sucrose, fructose, glucose, or the like). Forexample a composition of the present invention consisting essentially oflisted ingredients does not include a medicine for treating diabetes.

Although not limiting to the present invention, in an embodiment, it isbelieved that administering an embodiment of the present composition canresult in greater reduction in mammalian blood glucose levels than acomposition lacking one or more of these ingredients. Although notlimiting to the present invention, in an embodiment, it is believed thatadministering an embodiment of the present composition can result ingreater reduction in mammalian blood glucose levels than would beexpected based on activities of the ingredients separately. Although notlimiting to the present invention, in an embodiment, it is believed thatadministering an embodiment of the present composition can result ingreater reduction in mammalian blood glucose levels than would beexpected based on components of the ingredients separately.

Insulin and Blood Glucose Levels

A diabetic subject taking the present composition may also be takinginsulin, which also affects blood glucose levels. A blood glucoseprofile (or curve) is a graph of blood glucose levels over time. It isan effective way to determine the type, dose, and frequency ofadministration of insulin or other medication, necessary to keep theblood glucose at acceptable levels. Each subject (e.g., dog) can responddifferently to insulin. Thus, the appropriate insulin therapy can bedetermined for each individual. In addition, a subject's (e.g., a dog's)insulin needs may change over time, so blood glucose profiles mayperformed periodically for the subject's lifetime.

By performing a blood glucose profile, a medical professional candetermine if an insulin was effective, when the peak effect occurred(i.e., when the glucose level was at its nadir (lowest point)), how longthe effect lasted, and the degree of fluctuation in the glucose level.Changes can then be made in the type of insulin or other medication, thedosage or the dosing intervals in order to maintain the blood glucose atthe optimal level throughout a 24-hour period. In some cases, up to fiveor more blood glucose curves may need to be performed before asatisfactory regimen is determined. In addition to the blood glucoseprofile, the response of the subject is noted. For example, for a dog,the amount the dog is eating, drinking, and urinating; activity level;and weight all help determine if the insulin regimen is effective.

Other medicines employed to treat diabetes include biguanides (e.g.,metformin), sulfonylureas (e.g., tolbutamide, glyburide, glipizide andothers), α-glucosidase inhibitors (e.g., acarbose and miglitol) andthiazolidinediones (e.g., troglitazone and rosiglitazone). A subjectreceiving the present composition may be taking one or more of thesemedicines.

With the FPG test, a fasting blood glucose level between 100 and 125mg/dl signals pre-diabetes. A person with a fasting blood glucose levelof 126 mg/dl or higher has diabetes. In the OGTT test, a person's bloodglucose level is measured after a fast and two hours after drinking aglucose-rich beverage. If the two-hour blood glucose level is between140 and 199 mg/dl, the person tested has pre-diabetes. If the two-hourblood glucose level is at 200 mg/dl or higher, the person tested hasdiabetes.

Embodiments of Methods

In addition, in an embodiment, it has been observed that administeringthe present composition to healthy dogs improved the condition of theirskin and/or coat and resulted in better overall general health (healthyweight and added lean muscle mass). In an embodiment, it has beenobserved that administering the present composition to dogs can improveskin condition, alleviate skin irritations, and facilitate general jointhealth. In an embodiment, it has been observed that administering thepresent composition can suppress appetite, influence weight loss, and/orincrease muscle mass.

In an embodiment, the present invention includes a method of assistingweight loss in a human in need thereof. This embodiment includesadministering the present composition. In an embodiment, the methodincludes administering to the dog a composition comprising: about 10 toabout 45 wt-% yeast; about 10 to about 70 wt-% bran; about 2 to about 30wt-% cinnamon; and about 5 to about 15 wt-% gelatin.

In an embodiment, the present invention includes a method of improvingthe quality of skin, hair, and/or nails in a human in need or desirousthereof. This embodiment includes administering the present composition.In an embodiment, the method includes administering to the dog acomposition comprising: about 10 to about 45 wt-% yeast; about 10 toabout 70 wt-% bran; about 2 to about 30 wt-% cinnamon; and about 5 toabout 15 wt-% gelatin.

The present invention may be better understood with reference to thefollowing examples. These examples are intended to be representative ofspecific embodiments of the invention, and are not intended as limitingthe scope of the invention.

EXAMPLES Example 1 A Composition of the Present Invention Decreased andSteadied Blood Glucose Levels in Diabetic Dogs

An embodiment of the present composition, when administered twice dailyto dogs also receiving insulin, resulted in decreased and steadied (moreconstant) blood glucose levels.

Materials and Methods Composition DT

wt-% Ingredient 14 brewer's yeast 14 wheat bran 14 oat bran 7 cinnamon 7wheat germ oil 7 gelatin 37 water

A single dose (treat) of composition DT is 0.75 ounces, which is 21grams. Each canine was given a dose of composition DT, depending ontheir weight, in the form of a treat. Large dogs were given 3 treats,medium dogs 2 treats, and small dogs 1 treat per dose. Each caninereceived its dose after each insulin injection and followed by foodtwice per day. All dogs were receiving insulin at 12-hour intervals.Blood glucose levels were checked 6-7 hours post-injection.

DT Dose Name Breed Veterinarian Insulin Units of Insulin (twice per day)FIG. Vincent Italian Greyhound A Vetsulin 24-28 decreased to 20 2  1Jackson Mixed A Vetsulin 20 1 2 and 3 Peanut Mixed A Vetsulin 20decreased to 18 1 4 and 5 Indiana Schnauzer B Vetsulin 20 decreased to17 2 6 and 7 then Humulin Toto Cairn Terrier A Vetsulin 6 decreased to 5½ 8 and 9 Babe Yellow lab mix C Vetsulin 38 decreased to 25 3 10 and 11then Humulin LuLu Welsh Corgi A Vetsulin decreased 2 12 and 13Pen/Border Collie then Humulin Piper Min Pin E Humulin 16 decreased to 81 14 Bailey Brittany Spaniel A Vetsulin to be determined 2 15 Mix thenHumulin Rusty Lassa Apsu A Humulin to be determined 2 16 Maddie GoldenRetriever D Vetsulin 36 decreased to 32 3

Results

Before receiving composition DT, glucose levels for all canines wereconsistently high and uncontrolled for a substantial period of time. Thedogs were typically taking maximum tolerated insulin doses. They couldnot maintain a consistent or normal blood glucose level while usinginsulin alone. Owners complained of their canine's excessive thirst andfrequent nightly urination problems. All dogs were monitored by theirveterinarian. Each of the plotted readings were taken 6-7 hours postinjection, which should be in the middle of the nadir curve, forconsistency and accuracy.

The combination of ingredients in composition DT produced positiveresults that are noticed quickly, usually within a few days. Duringtreatment with composition DT, without exception, all the dogs' bloodsugar levels were in the 75-140 normal range. The time to positiveresults seemed to be slightly longer for dogs receiving human insulin(e.g., HUMULIN N®) than VETSULIN®; 5 to 10 days compared to 2 to 5 days.Normal water consumption and lack of overnight urination resulted.

To demonstrate that composition DT was responsible for the decrease andsteadying of blood glucose levels, six of the dogs then received nocomposition DT for one to two weeks. The following week's blood glucoselevels were dramatically higher (242-586, FIGS. 3, 5, 9, 11, and 13).There was also a noticeable increase in water consumption and resultantfrequent urination. Upon reinstating composition DT, urination, waterconsumption and blood glucose quickly returned to normal.

In addition, composition DT allows for a decreased dose of insulin formany of the canines in the study. Insulin dosages in many of the testsubjects were dropped between 15-40%.

In two specific cases, diabetic dogs were given insulin shots andglucoses tested at 6 hours-post injection. These glucose levels were260, and 242 respectively. After approximately 2 months of treatmentwith composition DT, the glucoses of these dogs were tested again 6hours post insulin injection and were significantly reduced to 73, and97.

Each of the dogs with results shown in the graphs has continued to takecomposition DT up to the filing date of this application, which includesperiods from 6 to 18 months.

Additional benefits observed for the canines included: improved coatand/or skin; decreased or eliminated urinary tract infections; decreasedor eliminated cataract formation and eventual blindness; normal waterconsumption and less frequent urination; normal appetite; healthy weightgain; more alert, playful and they appear to feel better.

At one point during the testing, VETSULIN® was taken off the market bythe FDA. HUMULIN-N®, which is an insulin designed for humans, wassubstituted. This required adjustment of the insulin dosage. CompositionDT was effective with either insulin.

Observations on Individual Canines:

Vincent is a member of the inventors' household. He had been an activeand larger than usual Italian Greyhound weighing 22 pounds. As hedeveloped diabetes, some 14 months before receiving composition DT,Vincent began drinking 1-2 gallons of water each day and losing weightrapidly. Vincent was started on VETSULIN® at this time. By two monthsbefore receiving composition DT, Vincent was nearly blind and weighedonly 14 pounds. Blood glucose levels ranged from 275 to 392 (months −14to −2)

After two weeks receiving composition DT, his weight was up to 20 poundsand he looked well. He returned to a normal level of water consumption,normal urination and overall healthy outlook. These improvements havebeen maintained for more than 18 months.

In week 3, Jackson did not receive DT for four days prior to bloodglucose test, and level increased to 238.

Before entering the study, Peanut had been treated with insulin withoutattaining stable blood glucose levels. In week 3, Peanut did not receiveDT for four days prior to blood glucose test, and level increased tonear 300.

Indiana lost half of his body weight before starting composition DT.LuLu was due to be euthanized before starting on composition DT, but theimprovement due this composition has provided LuLu with a good qualityof life.

Maddie was also due to be euthanized before starting on composition DT,but she made a full recovery. While taking twice daily doses ofcomposition DT, Maddie was reported to be seizure free, to have brightereyes, to be very alert, to exhibit improved appetite with healthy weightgain. She went to the bathroom and walked outside by herself, isdrinking only normal amounts or water and has had no accidents.

Conclusions

An embodiment of the present composition, when administered twice dailyto dogs also receiving insulin, resulted in decreased and steadied (moreconstant) blood glucose levels. Essentially, the composition DT seemedto smooth out glucose levels.

Example 2 A Composition of the Present Invention Lowered Human BloodGlucose Levels

An embodiment of the present composition lowered human blood glucoselevels.

Materials and Methods Composition HB

wt-% Ingredient 12 brewer's yeast 12 wheat bran 12 oat bran 6 cinnamon 6wheat germ oil 6 gelatin 7 flavor (optional) 1 octacosanol (optional) 38water

A unit dose of composition HB is a 0.85 ounce (24 gram) portion (bar) ofthis mixture.

The subject of the study was a 47 year old male Caucasian non-diabetic,height 6′1″, and weight 225 pounds at the beginning of the study.Subject is a non-smoker and does a moderate level of exercise—walking3-4 miles/2(×) week.

This study included monitoring food intake and blood glucose levels atvarious critical times of the day. Subject tested blood glucose level atthe ½ hour range after a meal (maximum spike), 1 hour and 1.5 hourranges and after 2 hours (normal recovery time for non-diabetic).Subject purchased a blood glucose monitor, followed all instructions andtested for accuracy with its built in monitors.

Subject tracked all food and beverage intake and consumed 1 alcoholdrink (beer or wine) 5-6 nights per week with dinner. The subjectconsumed the same meals before and after the intake of composition HBfor comparison and accuracy. Exercise was monitored and consistentduring testing. Subject was taking vitamins and supplements prior to thestudy, but stopped taking any 10 days prior to the beginning of thestudy period.

The initial study was conducted for 23 days (part I) and continuedthereafter (part II on-going testing). The time period without the useof composition HB was 13 days of part I. The time period with the use ofcomposition HB was the other 10 days of part I. During this phase thedose was equal to one dose of composition HB, repeated three times perday, one before each meal. Composition HB was taken with 8-12 ounces ofwater prior to each meal.

The subject ate the same breakfasts with and without consumingcomposition HB. Breakfast #1—High 5 Breakfast: 2 eggs, 2 bacon, 2sausage, 1-12″ pancake with maple syrup, large portion hash browns,ketchup and 12 oz of Skim Milk and water. Breakfast #2—High Sugar/Carb:Bowl of shredded wheat squares, 8 oz skim milk, one medium organicorange and 10 oz of fresh pineapple.

Results Breakfast #1—FIG. 17

This breakfast was high in calorie, fat, sugar and carbohydrates. Bloodglucose tended to be kept in a tighter range without dramatic ranges(peaks and troughs). Although the subject felt full longer and had noneed to eat lunch, the subject felt good. Composition HB in the firsthour consistently reduced the upper blood glucose level by 30+ points(170 vs 140 at ½ hour and at one hour 166 vs 130 and 1.5 hours 145 vs.120). A subject should be back normal range of 120 or less no matterwhat they eat, assuming that they do not have diabetes or anotherproblem with control of blood glucose levels.

Breakfast #2 (Max Sugar)—FIG. 18

This breakfast was very high in sugar and carbohydrates. The subject didnot feel good after eating this breakfast. The subject's blood glucosereading spiked at the ½ hour level and dropped very rapidly in one hour.Blood glucose dropped approximately 100 points in the absence of dosingwith composition HB. In the first ½ hour the difference was 177 (none)vs. a range of 160. At the one hour time frame, it was 145 vs. 120 andat the 1½ hour span it was 124 vs 88 and at two hours all were in the 80range. This breakfast resulted in high highs and low lows all in a shorttime span and the subject felt the difference. With composition HB therange was 160 to 88 (total drop 72) and without 177 to 80 (total drop 97points).

Discussion

Using composition HB, the subject experienced more consistent bloodglucose levels with no noticeable spikes. Due to more consistent bloodglucose levels subject did not experience the afternoon drowsiness fromeating lunch after taking composition HB, which he had experienced foryears when not taking composition HB. Subject noticed consistent energylevel throughout the day. After long day of reading, the subject did notexperience the 5:30 p.m. blurred vision due to the drop in blood sugarlevels prior to dinner. General eye strain from working on a computerwas alleviated. Subject also observed that cravings for sugar werecurbed.

Upon a medical examination by a doctor who also reviewed the datareported here, the doctor concluded that the subject would be likely todevelop Type II Diabetes if left unchecked. Also, the upper ranges aftereating breakfast also indicated pre-diabetes.

Subject's spouse has no blood glucose issues and observed thatcomposition HB acted as a multi-vitamin, but had little or no effect onher blood glucose readings. However, it was observed that effects oftaking composition HB included noticeable weight loss, skin, hair, nailimprovement, and reduced cholesterol. Taking composition HB, the spouselost 8 pounds that she had been unable to lose even when she had beenfollowing a very strict diet without taking composition HB.

Example 3 A Form of A Composition of the Present Invention in a GelatinCapsule

A capsule form of the present composition included:

Composition HC

wt-% Ingredient 33 brewer's yeast 19 wheat bran (powder) 19 oat bran(powder) 19 cinnamon 9 gelatin 1.6 chromium enriched yeast (optional)

Composition HC was in a gelatin capsule. Composition HC can beadministered with a 1 g dose of wheat germ oil. The wheat germ oil canalso be in a gelatin capsule. In an embodiment, the present compositionincludes one or more capsules of composition HC and wheat germ oil,e.g., capsules containing wheat germ oil.

Composition HC can be administered to an adult human in doses of 0.22 oz(6.4 g), the dose being repeated 3 times per day. In an embodiment,composition HC can be administered in capsules containing 0.032 oz (0.9g) each, which amounts to 7 capsules per dose.

Example 4 A Composition of the Present Invention Showed No Side-Effectsin Healthy Humans

An embodiment of the present composition was evaluated in a Phase Iclinical trial for its safety and effect on blood glucose levels inhealthy humans.

Protocol

This study evaluated the change in glucose levels and insulin levels innormal healthy subjects after taking composition HB initially and afterone week. The dosage was two 0.85 ounce bars of composition HB takenthree times per day. The study was conducted according to all relevantsafeguards, institutional requirements, and regulatory agencyrequirements.

The study included measuring changes in glucose over time; evaluatingthe peak and trough action of composition HB or HC on glucose atbaseline; evaluating the peak and trough action of composition HB or HCon insulin levels at baseline; evaluating the peak and trough glucoselevels after a week long loading dose; and/or evaluating the peak andtrough insulin levels after a week long loading dose.

This exploratory pilot study was a non-blind, single-subject design thatevaluated 10 non-diabetic subjects' insulin and glucose responses tocomposition HB. Subjects took part in the study for up to 14 days. Therewere two phases to the study. Phase I included screening and baselineassessments for self-comparison in the absence of treatment. Phase IIincluded the same assessments in the presence of treatment with anexemplified embodiment of the claimed composition.

Exclusion criteria included, for example, in the opinion of theinvestigator the subject was not a good candidate for the study; thesubject had current and active liver or kidney disease; lababnormalities of greater than 3 times the upper limit of normal for anylab value; and/or diabetes.

The study procedures included one of more of the following:

Treatment Glucose and Baseline/ insulin Treatment End of Screeningbaseline start Treatment VISIT 1 2 3 4 Day −7  1 7 14  PROCEDURE MedicalHistory x x Physical Exam x x x CBC with differential x Comprehensive xMetabolic Panel Hemaglobin A1C x Glucose tolerance test x Glucosetolerance test x x with composition HB or HC Insulin levels x x x VitalSigns (weight, x x x blood pressure, pulse, temperature) Concomitant x xx x Medication Adverse Event Review A symptoms diary will x x bedispensed/collected Dispense composition x HB or HC Record Adverse x x xEffects Administer x Questionnaires

Results

A preliminary phase I clinical study administering composition HB wasconducted with healthy individuals to establish safety and to determineside effects. Eleven subjects were recruited for the study. One subjectsigned consent and then withdrew after one visit. Five subjects startedthe study and withdrew consent after one week on study. The study endedwith five subjects completing three weeks of taking 2 doses ofcomposition HB three times per day.

The results showed minimal side effects. Five subjects reported nauseaand vomiting. Subjects monitored their glucose levels at home andexperienced no episodes of hypoglycemia. Composition HB was safe and hada slight effect on blood glucose and insulin levels in normalindividuals. Most subjects rated the taste, texture, and appearance ofthe product as unsatisfactory.

Discussion

Based on this phase I study, the institution that conducted the phase Istudy decided to conduct a double blind clinical trial involving 40 typeII diabetics. Then medical professionals planning the study expect thatthe composition of the present invention will have a greater effect ontype II diabetic individuals as they have less control of their bloodsugar than, for example, pre-diabetic individuals. The clinical trial isbeing conducted to demonstrate whether or not, by taking composition HCor composition HB, diabetics will be able to maintain a (more) stableblood glucose level and benefit from increased sensitivity to insulin.The research is also expected to show that diabetic individuals may beable to reduce their level of insulin and/or other medications whiletaking composition HC or composition HB.

Example 5 A Composition of the Present Invention is Studied for Safetyand Efficacy in Type-II Diabetic Humans

This study will be a phase II, placebo controlled, randomized, safetyand efficacy study to evaluate the change in hemoglobin A1C levels intype 2 diabetic subjects while taking composition HC.

Hypothesis

The hypothesis of this study is that diabetic subjects will decreasehemoglobin A1C levels by ≧2.0 after taking composition HC for 26 weeks.This is a phase II safety and efficacy study to evaluate the change inhemoglobin A1C, glucose levels, and medication usage in diabeticsubjects while taking composition HC. Clinical outcomes are expected toinclude: hemoglobin A1C reduction; a reduction in blood glucose levels;reducing the amount of diabetes medication needed.

Protocol

Subjects will take part in the study for up to 26 weeks. All subjectswill be given placebo capsules for the first week, to measure complianceprior to randomization. The subjects will be type II Diabetics who havebeen stable on diabetes medication/Insulin for 3 months or greater.

Blood will be drawn for laboratory tests such as: comprehensivemetabolic panel, complete blood count, hemoglobin A1C, chromium levels,insulin level, C-peptide levels (to verify the subject is a type IIdiabetic), fasting insulin levels, genetic analysis (endocrineexpression genetics), and the like.

Example 6 A Composition of the Present Invention Reduced Seizures inDogs

An embodiment of the present composition, when administered twice dailyto dogs that suffer from seizures, reduced the number of seizures.

Materials and Methods

Each canine was given a dose of composition DT, depending on theirweight, in the form of a treat. Large dogs were given 3 treats, mediumdogs 2 treats, and small dogs 1 treat per dose. Each canine received itsdose followed by food twice per day.

Results

Leo, the 6-year old brother of Vincent, formerly suffered from about 2seizures per year, typically when over excited. In the 15 months ofreceiving twice daily doses of composition DT, Leo has suffered noseizures. His coat and skin have also improved.

Charlie is a beagle who suffered from regular seizures. He was oncomposition DT without seizures for a period of about one month.Composition DT was removed for ten days, during which time Charlie had aseizure. After resuming treatment with composition DT, Charlie has goneseveral months without a seizure.

Maddie had been having 2 or 3 seizures per day before startingcomposition DT. She has had no seizures while receiving her twice dailydosage of composition DT.

Conclusions

An embodiment of the present composition, when administered twice dailyto dogs that suffer from seizures, reduced the number of seizures.

It should be noted that, as used in this specification and the appendedclaims, the singular forms “a,” “an,” and “the” include plural referentsunless the content clearly dictates otherwise. Thus, for example,reference to a composition containing “a compound” includes a mixture oftwo or more compounds. It should also be noted that the term “or” isgenerally employed in its sense including “and/or” unless the contentclearly dictates otherwise.

It should also be noted that, as used in this specification and theappended claims, the term “configured” describes a system, apparatus, orother structure that is constructed or configured to perform aparticular task or adopt a particular configuration. The term“configured” can be used interchangeably with other similar phrases suchas arranged and configured, constructed and arranged, adapted andconfigured, adapted, constructed, manufactured and arranged, and thelike.

All publications and patent applications in this specification areindicative of the level of ordinary skill in the art to which thisinvention pertains. All publications and patent applications are hereinincorporated by reference to the same extent as if each individualpublication or patent application was specifically and individuallyindicated by reference.

The invention has been described with reference to various specific andpreferred embodiments and techniques. However, it should be understoodthat many variations and modifications may be made while remainingwithin the spirit and scope of the invention.

1-9. (canceled)
 10. A method of reducing a blood glucose level in asubject in need thereof, the method comprising administering to thesubject a composition comprising: about 10 to about 45 wt-% yeast; about10 to about 70 wt-% bran; about 2 to about 30 wt-% cinnamon; and about 5to about 15 wt-% gelatin; wherein administering is effective to lowerthe required dose of insulin for effective glucose control and tostabilize blood glucose levels.
 11. The method of claim 10, wherein thesubject also receives insulin to control the blood glucose level. 12.The method of claim 11, comprising administering the composition withinone hour after the subject receives a dose of insulin.
 13. The method ofclaim 10, comprising administering the composition within one hourbefore a meal.
 14. The method of claim 10, wherein the compositionfurther comprises an ingredient selected from the group consisting of:about 5 to about 15 wt-% wheat germ oil; about 5 to about 30 wt-%flavoring; about 0.1 to about 2 wt-% octacosanol; about 0.5 to about 3wt-% chromium enhanced yeast; and a mixture thereof.
 15. The method ofclaim 10, wherein: the bran comprises approximately equal amounts ofwheat bran and oat bran.
 16. The method of claim 10, wherein thecomposition comprises: about 22 wt-% brewers yeast; about 44 wt-% bran;about 11 wt-% cinnamon; about 11 wt-% gelatin; and further comprisesabout 11 wt-% wheat germ oil.
 17. The method of claim 10, wherein thecomposition comprises: about 17 wt-% brewers yeast; about 34 wt-% bran;about 9 wt-% cinnamon; about 9 wt-% gelatin; and further comprises:about 9 wt-% wheat germ oil; about 17 wt-% flavoring; and about 0.7 wt-%octacosanol.
 18. The method of claim 10, wherein the compositioncomprises: about 33 wt-% brewers yeast; about 38 wt-% bran; about 19wt-% cinnamon; about 9 wt-% gelatin; and further comprises about 1.6wt-% chromium enhanced yeast.
 19. (canceled)
 20. The method of claim 10,wherein the subject is a human.
 21. The method of claim 10, wherein theyeast is selected from the group consisting of brewers yeast, chromiumenhanced yeast, and a mixture thereof.
 22. The method of claim 10,wherein: the bran comprises approximately equal amounts of wheat branand oat bran; and the yeast is selected from the group consisting ofbrewers yeast, chromium enhanced yeast, and a mixture thereof.
 23. Amethod of reducing a blood glucose level in a subject in need thereof,the method comprising administering to the subject a compositioncomprising: about 17 wt-% brewers yeast; about 34 wt-% bran; about 9wt-% cinnamon; about 9 wt-% gelatin; about 9 wt-% wheat germ oil; about17 wt-% flavoring; and about 0.7 wt-% octacosanol; wherein administeringis effective to lower the required dose of insulin for effective glucosecontrol and to stabilize blood glucose levels.
 24. The method of claim23, wherein the subject is a human.
 25. A method of reducing a bloodglucose level in a subject in need thereof, the method comprisingadministering to the subject a composition comprising: about 33 wt-%brewers yeast; about 38 wt-% bran; about 19 wt-% cinnamon; about 9 wt-%gelatin; and about 1.6 wt-% chromium enhanced yeast; whereinadministering is effective to lower the required dose of insulin foreffective glucose control and to stabilize blood glucose levels.
 26. Themethod of claim 25, wherein the subject is a human.